| Effect | Increase |
| Values | PSD subjective. Mean and SE. Placebo: before 2.78 (0.14), after 2.81 (0.12). Saffron: before 2.46 (0.14), after 2.99 (0.12) |
| Trial Design | Randomized trial |
| Trial Length | 1-6 months |
| Number of Subjects | 63 |
| Sex | Both Genders |
| Age Range | 18-29, 30-44, 45-64, 65+ |
In a 28-day randomized, double-blind, placebo-controlled trial, 63 healthy participants took 28 mg of saffron extract (Crocus sativus L. and standardized to contain more than 3.5% Lepticrosalides) or placebo daily.Funding issues for this study:
The primary outcome was insomnia severity according to the Insomnia Severity index, and there was a greater improvement in the saffron group. There wasn't a difference in the change in total sleep time or sleep latency, while the number of awakenings was lower and overall subjective sleep quality was higher. There wasn't a difference in mood open awaking, but alertness was improved, and participants reported more restorative sleep subjectively.
Adverse events weren't notably different.
The trial was preregistered: ACTRN12619000863134
"The authors gratefully acknowledge Pharmactive Biotech Products SL for funding
the project and supplying affron and LIPA Pharmaceuticals for the preparation of
the tablets"
